Novocellus Ltd (63% holding)

Introduction

Novocellus was set up by ANGLE plc, under its Progeny® programme, to develop and commercialise patented technology based on the research of Professor Henry Leese at the University of York. The technology, Amino Acid Profiling (AAP), is a quantitative, non-invasive method for selecting those embryos that are most likely to lead to a successful pregnancy and live birth. The product will be marketed as EmbryoSure™ and we expect its use to uplift overall pregnancy rates in IVF by at least 30%.

The Clinical Need

Infertility is a growing problem driven by environmental and lifestyle changes. This has led an increasing number of couples to seek infertility treatment, the best known of which is in vitro fertilisation or IVF. Current clinical practice in IVF relies on subjective methods of assessing embryo ‘quality’ and this has often resulted in low live birth rates (ca 20%). A consequence has been multiple embryo transfers, in an attempt to increase the pregnancy rate, leading to a high incidence of multiple births. This is significant in terms of increased risk to mother and a higher incidence of peri-natal mortality and birth defects.

These problems are being addressed through the increasing use of elective single embryo transfer (eSET), but this has led to an overall reduction in pregnancy rate per IVF cycle. Against this background, the global IVF clinical community has a serious unmet need for a more effective method of embryo assessment, if they are to offer success rates comparable to, or better than, those for multiple embryo transfer.

The Market Opportunity

In 2008, it is estimated that there will be over 1,000,000 cycles of IVF carried out globally, a figure that is growing at more than 4% a year. This represents a potential global market opportunity for EmbryoSure™ of $1.5 billion by 2015.

Adoption of EmbryoSure™ will be driven by the need of patients, healthcare providers and clinicians for a higher degree of certainty that the embryos being transferred are likely to lead to a successful pregnancy. This is particularly true for eSET and the increasing trend towards its use will be a significant driver of future revenue growth.

The Novocellus Solution

EmbryoSure™ involves measuring the turnover of natural amino acids by the embryo in its first 24 hours of development. This is done by analysing changes in the amino acid content of the medium in which the embryo has been cultured.

In practice, a small sample (2µl) of the spent culture medium is analysed using our patented technology. The output of the test is an Embryo Viability Score, based on AAP and standard morphological grading. This score is used by the embryologist to determine which embryo(s) are likely to result in a successful pregnancy. The selected embryo(s) can then either be transferred immediately or frozen for future use.

To test the clinical utility of the technology, i.e. “proof of principle”, EmbryoSure™ has already been evaluated in two pilot clinical studies at hospitals in the UK. These showed a significant correlation between the amino acid profiles, clinical pregnancy and live births.

Based on the pilot studies, it was concluded that AAP would be of value in predicting which embryos would be most likely to lead to a successful pregnancy and should result in at least 30% uplift in the clinical pregnancy rate.

Current Status

Novocellus is about to embark on a full scale Phase II/III clinical programme, with Phase II scheduled for completion in mid-2009 and Phase III planned to be complete in mid-2010. It is planned to seek CE marking of the product on completion of Phase II, with a view to UK launch of EmbryoSure™ in early 2010.

Website: www.novocellus.com

Novocellus Ltd Registered Office: 20 Nugent Road, Surrey Research Park, Guildford, Surrey GU2 7AF.
Registered in England No 04338807

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